Under the terms of the agreement, the Saint Regis Mohawk Tribe now owns exclusive license for all Orange Book-listed patents for Allergan’s Cyclosporine Ophthalmic Emulsion 0.05% (Restasis®). The Tribe will receive $13.75 million upon execution of the agreement, and it will be also eligible to receive $15 million in annual royalties.
Being recognised a sovereign tribal government, the Tribe will file a motion to dismiss the on going inter partes review (IPR) of the patents based on their sovereign immunity from IPR challenges. The agreement with the Tribe has no impact on the pending abbreviated new drug application (ANDA) patent litigations regarding the Restasis® patent family which recently completed a five-day trial in Federal District Court in Marshall, Texas.